Treatment of Faecal Incontinence With Sacral Nerve Stimulation - Improved Function With Stimulation Bilaterally? (SNS)

• ClinicalTrials.gov Identifier: NCT00913601
• Recruitment Status: Terminated
• First Posted: June 4, 2009
• Last Update Posted: July 3, 2014
• Sponsor: University of Aarhus
• Collaborator: MEDTRONIC DANMARK A/S Arne Jacobsens Alle 17 DK-2300 København S Danmark
• Information provided by (Responsible Party): Jakob Jakobsen, University of Aarhus

Tracking Information

• First Submitted Date: June 2, 2009
• First Posted Date: June 4, 2009
• Last Update Posted Date: July 3, 2014
• Study Start Date: May 2009
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 3, 2009): Number of faecal incontinence episodes per week. [ Time Frame: 1, 2, and 3 months after enrolment to the project ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 3, 2009)

• Days with faecal soiling. [ Time Frame: 1, 2, and 3 months after enrolment to the project ]
• Days with faecal urgency. [ Time Frame: 1, 2, and 3 months after enrolment to the project ]
• Wexner incontinence score. [ Time Frame: 1, 2, and 3 months after enrolment to the project ]
• Anal physiological changes during SNS bilateral versus unilateral. [ Time Frame: 1, 2, and 3 months after enrolment to the project ]
• Quality of life assessment (Rockwood - Fecal incontinence quality of life) [ Time Frame: 1, 2, and 3 months after enrolment to the project ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Treatment of Faecal Incontinence With Sacral Nerve Stimulation - Improved Function With Stimulation Bilaterally?
• Official Title: Treatment of Idiopathic Faecal Incontinence With Sacral Nerve Stimulation - Improved Function With Implantation and Stimulation of Permanent Electrodes Bilaterally - a Double-blinded Randomized Cross-over Trial
• Brief Summary: Faecal incontinence is a devastating condition causing psychological stress, affecting daily living and influences quality of life. Faecal incontinence affects 2,2 to 5 % of the adult population. The magnitude of the problem is probably underestimated, because most patients don't discuss this affliction with their general practitioner. A new treatment, sacral nerve stimulation (SNS), has over the last decade given hope to these patients. The treatment is divided in two; first a test operation (PNE-test) has to reveal if the patient will benefit from treatment with permanent sacral nerve stimulation. Second if the patient benefit from the PNE-test, they proceed to final implant. 75-80% of the patients with idiopathic fecal incontinence benefit from the PNE-test, 70% of those get satisfactory functional results and the remaining 30% get suboptimal improvement in continence after permanent unilateral sacral nerve stimulation. The aim of this project is to investigate if bilateral sacral nerve stimulation can produce better fecal continence results than standard unilateral stimulation, through a double blind, randomized crossover study.

Detailed Description

Sacral nerve stimulation is a very good and effective treatment for faecal incontinence The method was introduced to patients with voiding disorders in 1981. In 1995 sacral nerve stimulation was used for three patients with faecal incontinence, two were afterwards fully continent. The method has over the last decade been used increasingly in Europe. The method is now used routinely in the treatment of faecal incontinence in Europe.

Recent studies have shown that the effect of sacral nerve stimulation is due to a neuromodulation in the central nervous system, whereas direct stimulation of efferent nerves to anal sphincter and the pelvic floor has less significance.

The sacral nerve stimulation is performed in two steps, first a test stimulation, if positive the patients proceed to permanent implant.

Test stimulation (PNE-test) is performed over a 3 week period. If this test stimulation produces a decrease in incontinence episodes of more than 50 per cent, a permanent electrode and neurostimulator are implanted. The test period has a success rate of approximately 75-80% in patients with idiopathic fecal incontinence or incontinence after anal surgery. These 75-80% will normal be candidates to unilateral implantation of permanent electrode and neurostimulator.

All permanently implanted has less incontinence symptoms after the treatment. Satisfactory continence results after permanent implantation are seen in 70% of the patients, the remaining 30% only obtain a suboptimal efficacy. It is unclear whether these patients could have a more optimal function if they were stimulate on more than one sacral nerve simultaneously.

Hypothesis: Is it possible to improve the functional result in faecal incontinent patients treated with routine unilateral sacral nerve stimulation by stimulating the sacral nerves bilaterally.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Fecal Incontinence

Intervention

Device: Medtronic INTERSIM II - 3058

Medtronic INTERSIM II - 3058 Impuls Generator

Other Name: Impuls Generator

Study Arms

• Experimental: Dextra
  Unilateral sacral nerve stimulation dextra for 4 weeks
  Intervention: Device: Medtronic INTERSIM II - 3058
• Experimental: Sinistra
  Unilateral sacral nerve stimulation sinistra 4 weeks
  Intervention: Device: Medtronic INTERSIM II - 3058
• Experimental: Bilateral
  Bilateral sacral nerve stimulation 4 weeks
  Intervention: Device: Medtronic INTERSIM II - 3058

Publications *

• Matzel KE, Stadelmaier U, Hohenfellner M, Gall FP. Electrical stimulation of sacral spinal nerves for treatment of faecal incontinence. Lancet. 1995 Oct 28;346(8983):1124-7.
• Vaizey CJ, Kamm MA, Turner IC, Nicholls RJ, Woloszko J. Effects of short term sacral nerve stimulation on anal and rectal function in patients with anal incontinence. Gut. 1999 Mar;44(3):407-12.
• Rasmussen OØ, Christiansen J. [Sacral nerve stimulation in fecal incontinence]. Ugeskr Laeger. 2002 Aug 12;164(33):3866-8. Danish.
• Jarrett ME, Mowatt G, Glazener CM, Fraser C, Nicholls RJ, Grant AM, Kamm MA. Systematic review of sacral nerve stimulation for faecal incontinence and constipation. Br J Surg. 2004 Dec;91(12):1559-69. Review.
• Michelsen HB, Buntzen S, Krogh K, Laurberg S. Rectal volume tolerability and anal pressures in patients with fecal incontinence treated with sacral nerve stimulation. Dis Colon Rectum. 2006 Jul;49(7):1039-44.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: July 2, 2014): 29
• Original Estimated Enrollment (submitted: June 3, 2009): 50
• Actual Study Completion Date: July 2013
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Informed Consent
• Diagnosed with idiopathic faecal incontinence and planned sacral nerve stimulation
• Age> 40 years normal sigmoid/colonoscopic prior to operation

Exclusion Criteria:

• Pregnant or breastfeeding
• Patients who are not deemed able to follow the planned testing program, including mental illness or mentally unstable patients
• Medication with known effects on gastrointestinal motility, thyroid disease, diabetes, coeliaki, neurological disorders.
• Irritable Bowel Syndrome

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT00913601
• Other Study ID Numbers: 001
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Jakob Jakobsen, University of Aarhus
• Study Sponsor: University of Aarhus
• Collaborators: MEDTRONIC DANMARK A/S Arne Jacobsens Alle 17 DK-2300 København S Danmark

Investigators

• Principal Investigator: Jakob K Jakobsen, MD; Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital, Denmark

• PRS Account: University of Aarhus
• Verification Date: July 2014